Following the peer review process, applications that an IC
may fund are reviewed for a number of other considerations. These include, as
applicable, alignment with NIH’s funding principles, review of the project
budget, assessment of the applicant’s management systems, determination of
applicant eligibility, and compliance with public policy requirements. The
applicant may be asked to submit additional information (such as other support
or verification of IACUC review) or to undertake certain activities (such as
negotiation of an F&A cost rate) in anticipation of an award. However, such
requests by NIH do not guarantee that an award will be made. Following review
of all applicable information, the IC will determine whether an award can be
made, if special conditions are required, and what level of funding is
appropriate.

Although these reviews and determinations occur before NIH
makes a new award, grantees must continue to comply with eligibility and public
policy requirements and maintain adequate management systems throughout the
period of support. The pre-award process for non-competing continuation awards
is a streamlined version of this process, including an assessment of progress
(see “Administrative
Requirements—Monitoring—Reporting—Non-Competing Grant Progress Reports”).

NIH uses just-in-time procedures for certain programs and
award mechanisms. These procedures call for limited information (e.g., a budget
justification and a biographical sketch) to be submitted with
investigator-initiated applications and allow for a possible NIH request for
additional information, including information concerning other support, when the
application is under consideration for funding. Just-in-time procedures also
allow an applicant to defer certification of IRB approval of the project’s
proposed use of human subjects, verification of IACUC approval of the project’s
proposed use of live vertebrate animals, and evidence of compliance with the
education in the protection of human research participants requirement until
after completion of the peer review and just prior to funding. (Applications in
response to RFAs also may be subject to these procedures. The RFA will specify
the timing and nature of required submissions.)

Information on other support
will be requested as part of the just-in-time procedures. IC scientific program
and grants management staff will review this information before award to ensure
the following:

lSufficient
levels of effort are committed to the project.

lThere is no scientific, budgetary, or commitment overlap.

ØScientific overlap occurs when (1) substantially the same
research is proposed in more than one application or is submitted to two or
more funding sources for review and funding consideration or (2) a specific
research objective and the research design for accomplishing the objective are
the same or closely related in two or more applications or awards, regardless
of the funding source.

ØBudgetary overlap occurs when duplicate or equivalent budgetary
items (e.g., equipment, salaries) are requested in an application but already
are provided by another source.

ØCommitment overlap occurs when an individual’s time commitment
exceeds 100 percent, whether or not salary support is requested in the
application.

Overlap, whether scientific,
budgetary, or commitment of an individual’s effort greater than 100 percent, is
not permitted. Any overlap will be resolved by the IC with the applicant and
the PI at the time of award.

lOnly
funds necessary to the approved project are included in the award.

For modular applications, the applicant is not required to
submit detailed budget information in the application. In lieu of the standard
budget forms, the applicant requests total direct costs for each year of
support requested. The request must be accompanied by budget narrative for all
personnel (by position, title, and level of effort), including consultants and
“to be appointed” positions, and, when applicable, for consortium/contractual
costs. NIH will request additional budget information in exceptional
circumstances only. Other support information will be requested only for
modular applications likely to result in an award. (See Subpart B of this part for more detailed
coverage of modular applications and awards.)

The amount of NIH funding is based on reasonable and
allowable costs consistent with the principles of sound cost management,
considering IC priorities (e.g., program relevance), constraints on the growth
of average grant costs, and available funds. NIH also has adopted the following
core funding principles specifically for research project grants:

lWhen
determining commitments for future years, NIH will consider stability of
support for investigators, optimum portfolio balance, and opportunities to
address emerging problems.

Eligibility

NIH awards may be made only to eligible applicants.
Continued funding is dependent on the grantee’s maintaining eligibility. In
general, domestic or foreign, public or private, non-profit or for-profit
organizations are eligible to receive NIH grants. However, on the basis of
statutory, regulatory, or published policy limitations, under certain programs
or types of awards, NIH may limit eligibility to, or exclude from eligibility,
classes or types of entities. Examples are limitations on the participation of
foreign entities, and programs under which only small businesses are eligible
applicants. The determination of eligibility includes verification of the
applicant’s status. The applicant may be required to provide proof of its status
by submitting documentation; otherwise the AOO’s signature on the application
certifies that the applicant is eligible to apply for and receive an award
(e.g., a small business applying under the SBIR or STTR programs).

In addition to reviewing organizational eligibility, NIH may
consider other factors relating to the applicant’s ability to responsibly
handle and account for Federal funds and to carry out the project. These
factors include the applicant’s intended role in the project, the location
where the project will be performed, the role of the PI in the project, and the
PI’s employment and citizenship status. Although some of these same
considerations are reviewed as part of the peer review, NIH’s concern at this
stage in the process is making an award to a legal entity that will be
accountable for both the performance of the approved project or activity and
the appropriate expenditure of funds. NIH will not make an award to an
applicant that does not have a substantive role in the project and would simply
serve as a conduit for another entity.

Generally, PIs and other personnel supported by NIH research
grants are not required to be U.S. citizens. However, some NIH
programs/mechanisms have a citizenship requirement. Any citizenship requirement
will be stated in the PA or RFA. In these cases, individuals are required to
have the appropriate citizenship status when the award is made rather than when
the application is submitted. For example, under K awards or Kirschstein-NRSA
individual fellowships, the individual to be trained must be a citizen or a
non-citizen national of the United States or have been lawfully admitted for
permanent residence at the time of award.

In the post-award phase, NIH monitors changes in grantee and
project status to ensure they meet legal and programmatic requirements and
takes actions necessary to protect the Federal government’s interests.

The GMO will ensure that a cost analysis is performed on any
application that requires a detailed budget. Cost analysis involves obtaining
cost breakdowns, validating cost data, evaluating specific elements of cost,
and examining data to determine the necessity for, and the reasonableness and
allowability of, the costs included in the application budget. The extent of
cost analysis will depend on the type of funding instrument and award
mechanism, the complexity of the project, prior experience with the applicant,
and other factors. Information on the applicable cost principles and on
allowable and unallowable costs under NIH grants is provided in “Cost Considerations.”

In addition to considering the specific information provided
in the application, the GMO determines the adequacy of the applicant’s
financial and business management systems that will support the expenditure of
and accountability for NIH funds. When an applicant has had no prior Federal grants
or cost-reimbursement contracts, the GMO may review the applicant’s financial
management and other management systems before award, or within a reasonable
time after award, to determine their adequacy and acceptability. For an
applicant with prior NIH or other Federal cost-reimbursement awards, the GMO
may review recent audit reports and other available information to determine
whether the applicant’s management systems meet the standards established in
45 CFR Part 74 or 45 CFR Part 92, as appropriate. The GMO will advise
the applicant if additional information is required. On the basis of the review
results, the GMO will determine the need for any corrective action and may
impose special conditions on the award.

The remainder of Part II serves as the terms and conditions
of NIH grants and cooperative agreements and is incorporated by reference in
all NIH grant and cooperative agreement awards. Subpart A includes those terms
and conditions that apply, in general, to NIH awards. Subpart B either expands
on Subpart A coverage or specifies additional or alternate terms and conditions
for particular types of awards, recipients, or activities.

These terms and conditions
are not intended to be all-inclusive. In addition to the requirements in the
NIHGPS, some of which repeat or highlight requirements found in the following,
NIH grants are subject to all of the applicable requirements of the following:

lAuthorizing
program legislation

lProgram
regulations, including those in 42 CFR Part 52

lOther
statutory requirements, such as those included in appropriations acts

lHHS
requirements in 45 CFR Part 74 or 45 CFR Part 92, as appropriate for the type
of recipient organization and the type of activity (e.g., research).

Notice of requirements not specified in the NIHGPS generally
will be provided in the NGA, but such notice is not required for the award to
be subject to the requirements of pertinent statutes and regulations. An
individual award also may contain award-specific terms and conditions. For
example, the GMO may include terms or conditions necessary to address concerns
about an applicant’s management systems.

Program and administrative policies and the terms and
conditions of individual awards are intended to supplement, rather than substitute
for, governing statutory and regulatory requirements. Thus, the requirements of
the NIHGPS apply in addition to governing statutory and regulatory requirements
not cited herein, and award-specific terms apply in addition to the
requirements of the NIHGPS.

This NIHGPS is written in “plain language” and is meant to
be an aid to the interpretation of statutory and regulatory requirements. These
terms and conditions are intended to be compliant with governing statutes and
the requirements of 45 CFR Parts 74 and 92, as modified by previously approved
waivers and deviations. However, in the case of a conflict, the statutes and
regulations govern.

If there is a perceived conflict between or among these
three categories of requirements—statutory and regulatory requirements, the
terms and conditions in the NIHGPS, and award-specific terms and conditions—or
if the grantee has other questions concerning award terms and conditions, the
grantee should request written clarification from the GMO. This may be done at
any time; however, if the inclusion of the term or condition would cause the
grantee not to accept the award or to be unable to comply, the question should
be raised before funds are requested from the HHS payment system. By drawing
funds from the HHS payment system, the grantee agrees to the terms and
conditions of the award.

Public Policy Requirements and Objectives

This section addresses public policy requirements and
objectives applicable to NIH awards. The term “public policy” indicates that
the requirement is based on social, economic, or other objectives or
considerations that may be attached to the expenditure of Federal funds by
grantees, consortium participants, and contractors, in general, or may relate
to the expenditure of Federal funds for research or other specified activities.
In addition to cross-cutting requirements that some or all Federal agencies
must apply to their grant programs, NIH grantees are subject to requirements
contained in HHS’s annual appropriations acts that apply to the use of NIH
grant funds, applicable provisions in other Federal agencies’ appropriations
acts, including Treasury, and other Federal statutes. Some of those
requirements are included here since they have been included in the
appropriations acts for several years without change, but those requirements
may be changed or other requirements may be added in the future.

NIH intends to uphold high ethical, health, and safety
standards in both the conduct of the research it funds and the expenditure of
public funds by its grantees. The public policy requirements specified in this
section set many of those standards. The signature of the AOO on the
application certifies that the organization complies, or intends to comply,
with all applicable certifications and assurances referenced (and, in some
cases, included) in the application instructions.

Instructions for applications
submitted on the PHS 398 include the following topics, which also are discussed
in this section of the NIHGPS:

lDebarment
and Suspension (specific certification language included in application
instructions)

As noted in this section, some certifications and assurances
may require submission of a separate document (e.g., human subjects assurance,
IRB certification, civil rights assurance). Applicants and grantees should take
particular note of these requirements (for example, see “Human Subjects” and “Civil
Rights”), the absence or inadequacy of which may delay an award or make an
applicant ineligible for award.

The grantee is responsible for establishing and maintaining
the necessary processes to monitor its compliance and that of its employees,
consortium participants, and contractors with these requirements; taking
appropriate action to meet the stated objectives; and informing NIH of any
problems or concerns.

If a grant is awarded on the basis of false or
misrepresented information, or if a grantee does not comply with these public
policy requirements, NIH may take any necessary and appropriate action,
including using any of the remedies described in “Administrative Requirements—Enforcement Actions”
or other available legal remedies.

Exhibit 2 contains information to help the grantee determine
what public policy requirements and objectives apply to its activities and
whether a requirement should be included in a consortium agreement or a
contract for routine goods or services under the grant (see “Glossary” for definitions). The exhibit
distinguishes between these types of transactions under a grant and indicates
(by “Y” for Yes or “NA” for Not Applicable) whether a given public policy
requirement normally would apply. However, even if the exhibit indicates that a
requirement is not applicable that public policy requirement potentially could
be applicable in a specific situation, e.g., if a contract under a grant
involves research activity. Therefore, this exhibit should be used as general
guidance only. The grantee should consult the terms and conditions of its award
and should contact the GMO if it has any question concerning the applicability
of a particular public policy requirement or objective.

Exhibit 2 also indicates where, in the NIHGPS, the
individual public policy requirements and objectives are covered in more
detail. The grantee should consult the governing statute, regulations, or other
cited policies or documents for complete information.

*A designation of NA in this table indicates that a particular
requirement does not apply to an otherwise eligible grantee, consortium
participant, or contractor or may not apply because the type of activity
covered is one not normally performed by such an entity.

Ethical and Safe Conduct in Science and
Organizational Operations

NIH grants are subject to requirements intended to ensure
that recipient organizations handle their Federal awards responsibly. Grantees
are required to adopt and enforce policies that minimize the opportunity for
improper financial gain on the part of the organization, its employees, and
organizations and individuals with whom they may collaborate, and that limit
the potential for research results to be tainted by possible personal financial
or other gain.

In addition, NIH grantees are expected to provide safe and
healthful working conditions for their employees and foster work environments
conducive to high-quality research.

NIH requires grantees to
establish safeguards to prevent employees, consultants, members of governing
bodies, and others who may be involved in grant-supported activities from using
their positions for purposes that are, or give the appearance of being,
motivated by a desire for private financial gain for themselves or others, such
as those with whom they have family, business, or other ties. These safeguards
must be reflected in written standards of conduct. Except as provided below,
NIH does not require a grantee to establish separate standards of conduct if it
maintains such standards for its non-grant-supported activities, as long as
those standards are consistent with State and local laws and cover, at a
minimum, expected conduct in regard to financial interests, gifts, gratuities
and favors, nepotism, and such other areas as political participation and bribery.
The standards also must do the following:

lAddress
the conditions under which outside activities, relationships, or financial
interests are proper or improper.

lProvide
for advance notification of outside activities, relationships, or financial
interests to a responsible organizational official.

lInclude
a process for notification and review by the responsible official of potential
or actual violations of the standards.

lSpecify
the nature of penalties that the grantee may impose. These penalties would be
in addition to any penalties that NIH or a cognizant Federal agency may impose
for infractions that also violate the terms or conditions of award.

The grantee is not required to submit its general standards
of conduct to NIH for review or approval. However, a copy must be made
available to each of its officers, each employee and consultant working on the
grant-supported project or activity, each member of the governing board, if
applicable, and, upon request, to NIH. The grantee is responsible for enforcing
its standards of conduct, taking appropriate action on individual infractions,
and, in the case of financial conflict of interest, informing the IC CGMO if
the infraction is related to an NIH award. (A listing of the NIH CGMOs is
available at http://grants.nih.gov/grants/stafflist_gmos.htm.)
If a suspension or separation action is taken by a grantee against a PI or
other key personnel under an NIH grant, the grantee must request prior approval
of the proposed replacement as specified in “Administrative Requirements—Changes in
Project and Budget—Prior-Approval Requirements.”

Financial
Conflict of Interest

NIH requires grantees and investigators to comply with the
requirements of 42 CFR Part 50, Subpart F, “Responsibility of Applicants for
Promoting Objectivity in Research for Which PHS Funding is Sought.” That
subpart promotes objectivity in research by establishing standards to ensure
that the design, conduct, and reporting of research funded under PHS grants or
cooperative agreements will not be biased by any conflicting financial interest
of an investigator. These requirements do not apply to Phase I of the SBIR/STTR
programs.

The signature of the AOO on
the face page of the application serves as certification of compliance with the
requirements of 42 CFR Part 50, Subpart F. Under those requirements the
organization must do the following:

lHave
a written and enforced administrative process to identify and manage, reduce,
or eliminate conflicting financial interests with respect to research projects
for which NIH funding is sought

lBefore
spending any NIH funds awarded under a new award, inform the CGMO of the
existence of any conflicting financial interests it identified of the type
covered by 42 CFR 50.605

lWhen
informing the CGMO that a financial conflict of interest has been identified,
ensure that the interest has been addressed in accordance with the regulations
by indicating whether the conflict has either been managed, reduced, or
eliminated

lContinue
to make similar reports on subsequently identified conflicts within 60 days of
identifying them

lMake
additional information available to NIH, upon request, as to how it handled
conflicting interests in accordance with the regulations.

As described in the
regulations, examples of how financial conflicts of interest might be addressed
include the following:

lPublic
disclosure of significant financial interests

lMonitoring
of research by independent reviewers

lModification
of the research plan

lDisqualification
from participation in all or a portion of the research funded by PHS

lDivestiture
of significant financial interests

lSeverance
of relationships that create actual or potential conflicts.

Grantees also must ensure that consortium agreements address
whether the consortium participant’s employees will be subject to the financial
conflict of interest requirements of the consortium participant or to those of
the grantee (see “Consortium Agreements”
in Subpart B of this part).

lMake
IRB members aware of the organization’s conflict of interest policies and
procedures.

lInclude
a statement in the informed consent form that all clinical investigators comply
with the organizational guidelines.

lAsk
investigators to complete a short questionnaire about whether they—or any
person responsible for the design, conduct, or reporting of research—have an
economic interest in or act as an officer or a director of any outside entity
whose financial interest could reasonably appear to be affected by the
research.

lInstruct
IRB members during their orientation on how to identify and respond to a
perceived financial, academic, or other conflict of interest.

HHS regulations published in
45 CFR Part 76 implement the government-wide debarment and suspension system
for HHS’ non-procurement transactions. “Non-procurement transactions” include grants,
cooperative agreements, scholarships, fellowships, and loans. Accordingly,
applicants for NIH grants (“primary covered transactions”), including
applicants for Kirschstein-NRSA individual fellowships, are required to certify[6] that, to the best of
their knowledge and belief, they and their principals (including PIs and other
key personnel)

lare
not presently debarred, suspended, proposed for debarment, declared ineligible,
or voluntarily excluded from covered transactions by any Federal department or agency;

lhave
not, within the 3-year period preceding the application, been convicted of, or
had a civil judgment rendered against them for

Øcommitting fraud or a criminal offense in connection with
obtaining, attempting to obtain, or performing a public (Federal, State, or
local) transaction or contract under a public transaction;

Øviolating a Federal or State antitrust statute;

Øembezzlement, theft, forgery, bribery, falsification or
destruction of records; or

Ømaking false statements or receiving stolen property;

lare
not presently indicted or otherwise criminally or civilly charged by a
governmental entity (Federal, State, or local) with commission of any of the
offenses enumerated above; and

lhave
not, within a 3-year period preceding the application, had any public
transaction (Federal, State, or local) terminated for cause or default.

If the applicant is unable to certify to these statements,
it must, nonetheless, submit the certification and attach an explanation. The
inability to certify does not automatically disqualify an organization from
receiving an NIH award; however, failure to submit the required certification
or the necessary explanation will cause NIH not to make an award. Appendix A of
45 CFR Part 76 contains the full text of the instructions and the
certification.

A variety of “lower-tier” transactions also are subject to
the certification requirement. Contractors under grants (where the contract
requires the provision of goods or services that will equal or exceed $100,000)
and all consortium participants must certify that they are not presently
debarred, suspended, proposed for debarment, declared ineligible, or
voluntarily excluded from participation in this transaction by any Federal
agency. Grantees also are required to obtain a certification from each trainee
under a Kirschstein-NRSA institutional research training grant before their
appointment. If an entity or individual is unable to certify to this effect, an
explanation should be attached to its proposal or to the document that defines
the legal relationship between the parties (for example, the consortium
agreement).

Regardless of whether a certification is required or made,
organizations or individuals that are suspended, debarred, or voluntarily
excluded from eligibility cannot receive NIH grants or be paid from NIH grant
funds, whether under a primary or lower-tier transaction, during the period of
suspension, debarment, or exclusion. Because individuals who have been
debarred, suspended, declared ineligible, or voluntarily excluded from covered
transactions may not receive Federal funds for a specified period of time,
charges made to the NIH grants for such individuals (e.g., salary) are
unallowable.

The Drug-Free Workplace Act of 1988 (Public Law 100-690,
Title V, Subtitle D, as amended) requires that all organizations receiving
grants from any Federal agency agree to maintain a drug-free workplace. By
signing the application, the AOO agrees that the grantee will provide a
drug-free workplace and will comply with the requirement to notify NIH if an
employee is convicted of violating a criminal drug statute. Failure to comply
with these requirements may be cause for debarment. HHS implementing
regulations are set forth in 45 CFR Part 76, “Governmentwide Debarment and
Suspension (Nonprocurement) and Governmentwide Requirements for Drug-Free
Workplace (Grants).”

Public
Health Security and Bioterrorism Preparedness and Response Act

The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (P.L. 107-188) is designed to provide protection against
misuse of select agents and toxins whether inadvertent or the result of
terrorist acts against the United States homeland or other criminal acts. The
Act was implemented, in part, through regulations published by CDC at 42 CFR 73, Select Agents
and Toxins. Those regulations supersede the requirements at 42 CFR 76.2
(Interstate Shipment of Etiological Agents), which established certain shipping
and handling requirements on laboratory facilities that send or receive select
agents. Copies of these regulations are available from the Import Permit
Program and Select Agent Program, respectively, CDC, 1600 Clifton Road, MS
E-79, Atlanta, GA 30333; telephone: 404-498-2255. These regulations also are
available at http://www.cdc.gov/od/ohs/biosfty/shipregs.htm.

Research involving select agents and recombinant DNA
molecules also is subject to the NIH Guidelines for Research Involving DNA
Molecules (NIH Guidelines) (see “NIH Guidelines
for Research Involving DNA Molecules and Human Gene Transfer Research” in
this subsection for applicability of these guidelines). The NIH Guidelines
apply to (1) research projects involving recombinant DNA that are conducted at
or sponsored by an organization that receives NIH support for recombinant DNA
research (for research performed abroad, the NIH Guidelines apply if the
research is supported by NIH funds) and (2) research projects involving testing
in humans of materials containing recombinant DNA developed with NIH funds, if
the organization that developed the materials sponsors or participates in those
projects. The NIH Guidelines are available at http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm.

USA PATRIOT Act

The Uniting and Strengthening America by Providing
Appropriate Tools Required to Intercept and Obstruct Terrorism Act (USA PATRIOT
Act) (P.L. 107-56) amends 18 U.S.C. 10 and provides criminal penalties for
possession of any biological agent, toxin, or delivery system of a type or in a
quantity that is not reasonably justified by a prophylactic, protective, bona
fide research, or other peaceful purpose. The Act also establishes restrictions
on access to specified materials. “Restricted persons,” as defined by the Act,
may not possess, ship, transport, or receive any biological agent or toxin that
is listed as a select agent (see “Public
Health Security and Bioterrorism Preparedness and Response Act” in this
subsection).

Additional Health and Safety
Regulations and Guidelines

Grantees are responsible for meeting Federal, State, and
local health and safety standards and for establishing and implementing
necessary measures to minimize their employees’ risk of injury or illness in
activities related to NIH grants. In addition to applicable Federal, State, and
local laws and regulations, the following regulations must be followed when
developing and implementing health and safety operating procedures and
practices for both personnel and facilities:

l29 CFR
1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure
to hazardous chemicals in laboratories; and other applicable occupational
health and safety standards issued by the Occupational Health and Safety
Administration (OSHA) and included in 29 CFR Part 1910. These regulations
are available at http://www.osha.gov/comp-links.html.

lPrudent
Practices for Safety in Laboratories (1995), National Research Council, National Academy Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055 (ISBN 0-309-05229-7). This publication can be obtained by telephoning 800-624-8373. It
also is available at http://www.nap.edu/catalog/4911.html.

Grantee organizations are not required to submit documented
assurance of their compliance with or implementation of these regulations and
guidelines. However, if requested by the awarding office, grantees should be
able to provide evidence that applicable Federal, State, and local health and
safety standards have been considered and have been put into practice.

Grantees are prohibited from knowingly using appropriated
funds to support activities that promote the legalization of any drug or other
substance included in Schedule I of the schedule of controlled substances
established by section 202 of the Controlled Substances Act, 21 U.S.C. 812.
This limitation does not apply if the grantee notifies the GMO that there is
significant medical evidence of a therapeutic advantage to the use of such drug
or other substance or that federally sponsored clinical trials are being
conducted to determine therapeutic advantage (see “Requirements Affecting the Rights and Welfare of
Individuals as Research Subjects, Patients, or Recipients of Services—Controlled
Substances”).

Lobbying

Recipients of Federal grants, cooperative agreements,
contracts, and loans are prohibited by 31 U.S.C. 1352, “Limitation on use of
appropriated funds to influence certain Federal contracting and financial
transactions,” from using appropriated Federal funds to pay any person for
influencing or attempting to influence any officer or employee of an agency, a
Member of Congress, an officer or employee of Congress, or an employee of a
Member of Congress with respect to the award, continuation, renewal, amendment,
or modification of any of these instruments. These requirements are implemented
for HHS in 45 CFR Part 93, which also describes types of activities, such as
legislative liaison activities and professional and technical services, which
are not subject to this prohibition.

Applicants for NIH awards
with total costs expected to exceed $100,000 are required to certify that they

lhave
not made, and will not make, such a prohibited payment;

lwill
be responsible for reporting the use of nonappropriated funds for such
purposes; and

lwill
include these requirements in consortium agreements and contracts under grants
that will exceed $100,000 and obtain necessary certifications from those
consortium participants and contractors.

NIH appropriated funds may not be used to pay the salary or
expenses of an employee of a grantee, consortium participant, or contractor or
those of an agent related to any activity designed to influence legislation or
appropriations pending before Congress or any State legislature. This
prohibition extends to the use of funds for publicity or propaganda purposes,
including the preparation, distribution, or use of any kit, pamphlet, booklet,
publication, radio, television, or video presentation designed to support or
defeat legislation pending before Congress or a State legislature except in
presentation to the Congress or State legislature itself or as part of normal,
recognized legislative-executive relationships. Also see Cost Considerations—Allowability of Costs and
Activities—Selected Items of Cost.”

Research Misconduct

The grantee will inquire into and, if necessary, investigate
and resolve promptly and fairly all instances of alleged or apparent research
misconduct. Title 42 CFR Part 50, Subpart A, “Responsibilities for PHS
Awardee and Applicant Institutions for Dealing With and Reporting Possible
Misconduct in Science,” specifies grantee responsibilities in dealing with and
reporting possible research misconduct. By signing the application, the AOO
certifies that the organization has established administrative policies as
required by 42 CFR 50, Subpart A, and will comply with those policies and
the requirements of the regulations. The regulations are available from the ORI
on its home page (http://www.ori.dhhs.gov) and, in hard copy, at the address
shown in Part III.

As stated throughout the NIHGPS, the grantee has primary
responsibility for ensuring that it is conducting its NIH-funded project in
accordance with the approved application and budget and the terms and
conditions of the award. The grantee must carry out its responsibilities with
extra care where research misconduct has been found or where a research
misconduct investigation has been initiated, as specified in 42 CFR 50.103
and 50.104. The grantee must report promptly to ORI any incident of alleged or
apparent research misconduct that it judges as warranting investigation and
must advise ORI of any decision to initiate an investigation. The regulations
also require that the grantee submit an annual report (see “Administrative Requirements—Monitoring—Reporting”).

If a misconduct investigation has been initiated, the
grantee must take any necessary steps, in addition to its normal and ongoing
responsibilities under the grant, to protect the scientific integrity of the
project, protect human subjects and animals, provide reports to ORI, and ensure
the proper expenditure of funds and continuation of the project during the
investigation, if appropriate. ORI staff members are available to help grantees
with investigating and reporting on research misconduct, and IC staff members
are available to provide technical assistance and to work with grantees to
protect funded projects from the adverse effects of research misconduct.

The grantee is responsible for the actions of its employees
and other research collaborators, including third parties, involved in the
project. When the grantee finds research misconduct by anyone working on an NIH
grant-supported project, whether at the grantee organization or at a
third-party organization, the grantee must assess the effect of that finding on
the ability to continue that project, as originally approved by NIH, and must
promptly obtain NIH approval of any intended change of PI or other key
personnel. Examples of possible sanctions by NIH are withdrawal of approval of
the PI or other key personnel, debarment, disallowance of costs associated with
the invalid or unreliable research, withholding of a continuation award, or
suspension or termination, in whole or in part, of the current award. These
actions are described in “Administrative
Requirements—Enforcement Actions.”

Where research misconduct has affected data validity or
reliability, ORI or NIH may require the grantee and its employee/collaborator
authors to submit a correction or retraction of the data to a journal, publish
the corrected data, or both. If the grantee does not comply with this
requirement, NIH may invoke its rights, under 45 CFR Part 74 or 92, to access
the data (including copyrightable material developed under the award), have the
data reviewed, and submit the correction.

The grantee must promptly report issues involving potential
criminal violations, such as misappropriation of Federal funds, to the HHS OIG
(see Part III).

NIH Guidelines for Research Involving
Recombinant DNA Molecules
and Human Gene Transfer Research

The NIH Guidelines for Research Involving Recombinant DNA
Molecules (NIH Guidelines) (April 2002 or latest revision) apply to all
research projects that involve recombinant DNA and are conducted at or
sponsored by an organization that receives NIH support for recombinant DNA
research. A copy of the NIH Guidelines is available at http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm.
As defined by the NIH Guidelines, recombinant DNA molecules are either (1)
molecules that are constructed outside of living cells by joining natural or
synthetic DNA segments to DNA molecules that can replicate in a living cell or
(2) molecules that result from the replication of those described in (1). The
NIH Guidelines apply to both basic and clinical research studies. Recombinant
DNA research involving select agents also is subject to pertinent CDC and USDA
regulations.[7]
Specific guidance for the conduct of human gene transfer studies appears in
Appendix M of the NIH Guidelines. Failure to comply with these requirements may
result in suspension or termination of an award for recombinant DNA research at
the organization, or a requirement for NIH prior approval of any or all
recombinant DNA projects at the organization. Two specific requirements of the
NIH Guidelines are discussed below, but the grantee should carefully review the
NIH Guidelines in their entirety to ensure compliance with all of the
requirements for projects involving recombinant DNA techniques.

Each organization that conducts research involving
recombinant DNA, including contractors under grants, must have policies and
procedures to ensure compliance with the NIH Guidelines and must establish a
standing IBC. The IBC is required to review each proposed project for
recombinant DNA experiments and certify that the procedures, project,
personnel, and facilities are adequate and in compliance with the NIH
Guidelines. Section IV of the NIH Guidelines specifies the composition of IBCs.
A roster of the IBC members must be submitted to NIH’s OBA (see Part
III for address). At a minimum, the roster should include the names,
addresses, occupations, and qualifications of the chairperson and members of
the committee. The roster also should indicate which IBC members are serving as
the chairperson, contact person, and, as applicable, experts in biosafety or
plant, animal, or human experimentation. Section IV of the NIH Guidelines also
specifies the roles and responsibilities of PIs and grantees in relation to
IBCs and in other areas.

Appendix M-I-C-4 of the NIH Guidelines requires serious
adverse events that are unexpected and are possibly associated with human gene
transfer intervention to be reported to OBA and the IBC within 15 calendar days
of investigator notification of the sponsor, or within 7 days if
life-threatening or fatal. In addition, annually, investigators must submit to
OBA certain information about protocols. Further information about the content
of these reports can be found in Appendix M-I-C-3 of the NIH Guidelines.

Nondelinquency on Federal Debt

The Federal Debt Collection Procedures Act of 1990 (Act), 28
U.S.C. 3201(e), provides that an organization or individual that is indebted to
the United States, and has a judgment lien filed against it, is ineligible to
receive a Federal grant. NIH cannot award a grant unless the AOO of the
applicant organization (or individual in the case of a Kirschstein-NRSA individual
fellowship) certifies, by means of his/her signature on the application, that
the organization (or individual) is not delinquent in repaying any Federal
debt. If the applicant discloses delinquency on a debt owed to the Federal
government, NIH may not award the grant until the debt is satisfied or
satisfactory arrangements are made with the agency to which the debt is owed.
In addition, once the debt is repaid or satisfactory arrangements made, NIH
still will take that delinquency into account when determining whether the
applicant would be responsible with respect to an NIH grant, if awarded.

Anyone who has been judged to be in default on a Federal
debt and who has had a judgment lien filed against him or her should not be
listed as a participant in an application for an NIH grant until the judgment
is paid in full or is otherwise satisfied. No funds may be rebudgeted following
an award to pay such an individual. NIH will disallow costs charged to awards
that provide funds to individuals in violation of this Act.

These requirements apply to all types of organizations and
awards, including foreign grants.

NIH Guidelines for Research Using Human
Embryonic Stem Cells

NIH will fund research using human pluripotent stem cells
derived from human embryos (technically known as human embryonic stem cells) or
human fetal tissue (technically known as human embryonic germ cells). For
purposes of these NIH Guidelines, human pluripotent stem cells are cells that
are self-replicating, are derived from human embryos or human fetal tissue, and
are known to develop into cells and tissues of the three primary germ layers.
Although human pluripotent stem cells may be derived from embryos or fetal
tissue, such stem cells are not in themselves embryos.

NIH research funded under
these Guidelines will involve human pluripotent stem cells derived: (1) from
human fetal tissue or (2) from human embryos that are the result of in vitro
fertilization and meet the following Presidential criteria. On August 9, 2001
at 9:00 p.m. EDT, the President announced his decision to allow Federal funds
to be used for research on existing human embryonic stem cell lines as long as
prior to his announcement (1) the derivation process. (which begins with
removal of the inner cell mass from the blastocyst) had already been initiated
and (2) the embryo from which the stem cell line was derived no longer had the
possibility of development as a human being.

In addition, the President established the following
criteria that must be met:

lThe
stem cells must have been derived from an embryo that was created for
reproductive purposes.

In order to facilitate research using human embryonic stem
cells, the NIH Human Embryonic Stem Cell Registry lists the human embryonic
stem cells that meet the eligibility criteria. The laboratories or companies
that provide the cells listed on the Registry must have submitted to NIH a
signed assurance. Each provider must retain for submission to NIH, if
necessary, written documentation to verify the statements in the signed
assurance. The Registry is accessible to investigators on the NIH home page at http://escr.nih.gov/.
Requests for Federal funding must cite a human embryonic stem cell line that is
listed on the NIH Registry.

Although NIH withdrew those sections of the NIH
Guidelines for Research Involving Human Pluripotent Stem Cells (http://stemcells.nih.gov/policy/guidelines.asp)
that pertain to research involving human pluripotent stem cells derived from
human embryos, the NIH Guidelines contain important and current information
regarding specific types of research that are eligible and ineligible for NIH
funding.

Pursuant to EO 13043 (April 16, 1997), Increasing the
Use of Seat Belts in the United States, NIH encourages grantees to adopt and
enforce on-the-job seat belt policies and programs for their employees when
operating vehicles, whether organizationally owned or rented or personally
owned.

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